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Table 2 Clinical trials of OVs

From: Oncolytic viruses for triple negative breast cancer and beyond

Virus Disease Modification Intervention/treatment Phase Number enrolled dosage-regimen Primary outcome measure Secondary outcome measure Status NCT number
Adenovirus Malignant Solid Tumor Armed with granulocyte-macrophage colony stimulating factor (GMCSF) CGTG-102 I 12 Intratumoral
intravenous
Safety and tolerability;
Dose Limiting Toxicities (DLT)
Response rate; disease control rate; progression free and overall survival Completed NCT01598129
Ovarian Cancer;
Primary peritoneal cancer
E1A gene deletion. RGD motif binds to integrins avb3 and avb5 Ad5-delta24RGD I 26 Intraperitoneal Maximum tolerated dose (MTD);
Spectrum of toxicities
Biologic, immunologic and anti-tumor effects of Ad5-delta24RGD Completed NCT00562003
Recurrent platinum resistant ovarian cancer Developed through a process of bio-selection Enadenotucirev I 38 Intravenous Maximum tolerated dose (MTD)   Completed NCT02028117
Pancreatic cancer Encoding TMZ-CD40L and 4-1BBL(LOAd-703) LOAd-703;
Gemcitabine;
nab-paclitaxel;
atezolizumab
I/ II 43 Intratumoral Number of patient with dose-limiting toxicities (DLTs) Overall Response Rate;
Overall Survival
Recruiting NCT02705196
Reovirus Metastatic Breast Cancer No modification Paclitaxel Reolysin II 81 Intravenous Progression free survival Response rate; Tumor and tissue response of potential molecular factors; Number of patients with adverse events Completed NCT01656538
Herpes Simplex Virus Solid tumor A spontaneously attenuated mutant TBI-1401(HF10) I 6 Intratumoral Safety and tolerability Overall tumor response;
Levels of antibody to HSV-1
Completed NCT02428036
Brain tumors Deletion of both copies of the γ1 34.5 gene and a disabling lacZ insertion in UL39 gene (G207) G207 I 15 Intratumoral Safety and tolerability Progression Free Survival;
Overall Survival
Recruiting NCT03911388
Rhabdomyosarcoma; Osteosarcoma and other RL1 gene deletion HSV1716 I 18 Intravenous;
Intratumoral
Safety of intratumoral injection or intravenous infusions Antiviral immune response Completed NCT00931931
Pancreatic cancer Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor(OH2) OH2 I/ II 25 Intratumoral The objective response rate Safety;
The disease control rate;
The duration of response;
The progression free survival;
Recruiting NCT04637698
Vaccinia Virus Advanced solid tumor Encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase GL-ONC1 I 43 Intravenous Safety and tolerability Detection of virus delivery to primary and/or metastatic tumors;
Evaluation of anti-vaccinia virus immune response;
Determine recommended dose and schedule for future investigation
Completed NCT00794131
Hepatocellular Carcinoma (HCC) Thymidine Kinase deletion;
Arm with GM-CSF
JX-594 II 30 Intratumoral Proportion of Subjects Achieving Disease Control; Safety and tolerability;
Number of Subjects Achieving Disease Control;
Median Overall Survival
Completed NCT00554372
Hepatocellular Carcinoma (HCC) Thymidine Kinase deletion;
Arm with GM-CSF
Pexastimogene Devacirepvec (Pexa Vec/JX-594) Sorafenib III 459 Intratumoral Overall Survival; Overall Response Rate (ORR); Time to Progression (TTP); Progression Free Survival (PFS); Overall Response Rate (ORR); Disease Control Rate (DCR); Incidence of Adverse Events (AE); Serious Adverse Events (SAE);
Time to Symptomatic Progression (TSP)
Completed NCT02562755
Measles virus Ovarian cancer Expressing carcinoembryonic antigen(MV-CEA)
Encoding thyroidal sodium iodide symporter (MV-NIS)
MV-CEA, MV-NIS I 37 Intraperitoneally Dose limiting Toxicity (DLT);
Maximum tolerated dose (MTD)
Number of Responses;
CA-125 levels;
Time to Progression
Completed NCT00408590